Regulation

The Mobile Health Apps tool aims to help developers determine which federal laws apply and which agencies oversee different aspects of mobile health technology.

Former CEO Elizabeth Holmes was sentenced to more than 11 years in prison last month.

The company pitches iQuest as a way for physicians to provide more precise cancer treatment and lessen the likelihood of negative side effects.

The Patent Trial and Appeal Board determined three AliveCor patents regarding the detection of heart conditions like cardiac arrhythmias were unpatentable.

EchoGo Heart Failure, developed in partnership with the Mayo Clinic, helps physicians detect heart failure with preserved ejection fraction.

The Israeli startup said it's now focused on receiving clearance to use its AEYE-DS system with a portable camera.

Elizabeth Holmes, founder of the scandal-ridden blood-testing startup, was found guilty on four of eleven charges in January.

When determining approval for Breakthrough Device designation, the FDA will consider whether the device addresses present health inequities.

David Rosen, a partner and public policy lawyer at Foley & Lardner, discusses the agency's recently wrapped Software Precertification Pilot Program and what it means for the future of digital health regulation.

The company said the clearance will allow more pharma companies to use Tasso+ for decentralized clinical trials.